Chin pivot patient interface device

ABSTRACT

A patient interface device that includes a body portion comprising a pair of arms and a chin support. A first end portion of each arm in the pair of arms is coupled to an opposite end of the chin support. The chin support is adapted to be disposed under the mandible responsive to the patient interface device being donned by a user. At least one headgear attachment element is provided on each arm in the pair of arms. A circuit portion is provided at a second end portion of each arm in the pair of arm. A patient interface portion is coupled to the circuit portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) fromprovisional U.S. patent application No. 60/814,356, filed Jun. 16, 2006,the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to patient interface device, and, inparticular, to a patient interface device is supported, at least inpart, under the mandible.

2. Description of the Related Art

There are numerous situations where it is necessary or desirable todeliver a flow of breathing gas non-invasively to the airway of apatient, i.e., without intubating the patient or surgically inserting atracheal tube in the esophagus. For example, it is known to ventilate apatient using a technique known as non-invasive ventilation. It is alsoknown to deliver continuous positive airway pressure (CPAP) or variableairway pressure, such as a bi-level pressure that varies with thepatient's respiratory cycle or an auto-titrating pressure that varieswith the monitored condition of the patient. Typical pressure supporttherapies are provided to treat a medical disorder, such as sleep apneasyndrome, in particular, obstructive sleep apnea (OSA), or congestiveheart failure.

Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface device, which is typically a nasal ornasal/oral mask, on the face of a patient to interface the ventilator orpressure support system with the airway of the patient so that a flow ofbreathing gas can be delivered from the pressure/flow generating deviceto the airway of the patient. It is known to maintain such masks on theface of a patient by a headgear having upper and lower straps, eachhaving opposite ends threaded through connecting elements provided onthe opposite sides and top of a mask.

Because such masks are typically worn for an extended period of time, avariety of concerns must be taken into consideration. For example, inproviding CPAP to treat OSA, the patient normally wears the patientinterface device all night long while he or she sleeps. One concern insuch a situation is that the patient interface device is as comfortableas possible, otherwise the patient may avoid wearing the interfacedevice, defeating the purpose of the prescribed pressure supporttherapy. It is also important that the interface device provides a tightenough seal against a patient's face without discomfort. A problemarises in that in order for the mask to maintain a seal without anyundue gas leaks around the periphery of the mask, the mask cushion maybe compressed against the patient's face. This is most notable, forexample, in masks having a bubble type cushion. While the bubble cushionitself is comfortable, it does not provide adequate support, which maycause gas leaks around the periphery of the mask. The bubble effect isdiminished when the headgear strap force is increased to improvestability.

Some conventional respiratory masks attempt to enhance mask stability byproviding a relatively large structure that must be mounted on thepatient's face. Therefore, an advantage exists for a respiratory maskthat minimizes the amount of material that must be supported on thepatient's head and face, yet provides a relatively high degree ofstability, so that that the mask is not easily dislodged from thepatient. Another advantage exists for a respiratory mask that evenlydistributes the headgear strapping force needed to hold the mask on thepatient at locations on the patient's face that are best suited tohandle such forces.

A further advantage exists for a respiratory mask that avoids providingany structural features near the patient's eyes. This advantage isparticularly important for patient's who desire to where glasses whilewearing the mask and for patient's that tend to feel claustrophobic whena structure is provided at or near their eyes. Avoiding the ocular areaalso eliminates or avoids the leakage of gas into the user's eyes, whichcan cause great discomfort. A still further advantage exists for a maskthat accomplishes these functions while also minimizing the headgearstrapping forces needed to pull the mask against the user, so that aneffective seal against the user is achieved without undue forces beingapplied on the user.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide apatient interface device that overcomes the shortcomings of conventionalpatient interface device. This object is achieved according to oneembodiment of the present invention by providing a patient interfacedevice that includes a body portion comprising a pair of arms and a chinsupport. A first end portion of each arm in the pair of arms is coupledto an opposite end of the chin support. The chin support is adapted tobe disposed under the mandible responsive to the patient interfacedevice being donned by a user. At least one headgear attachment elementis provided on each arm in the pair of arms. A circuit portion isprovided at a second end portion of each arm in the pair of arm. Apatient interface portion is coupled to the circuit portion.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a first embodiment of a patientinterface device according to the principles of the present invention;

FIGS. 2-4 are a side, front, and exploded views, respectively, of thepatient interface device of FIG. 1;

FIG. 5 is a front perspective view of a second embodiment of a patientinterface device according to the principles of the present invention;

FIGS. 6-8 are a side, front, and exploded views, respectively, of thepatient interface device of FIG. 5;

FIG. 9 is a front perspective view of a third embodiment of a patientinterface device according to the principles of the present invention;

FIGS. 10-12 are a side, front, and exploded views, respectively, of thepatient interface device of FIG. 9;

FIG. 13 is a front perspective view of a fourth embodiment of a patientinterface device according to the principles of the present invention;

FIGS. 14-16 are a side, front, and exploded views, respectively, of thepatient interface device of FIG. 13;

FIG. 17 is a front perspective view of a fifth embodiment of a patientinterface device according to the principles of the present invention;

FIGS. 18-20 are a side, front, and exploded views, respectively, of thepatient interface device of FIG. 17;

FIG. 21 is a front perspective view of a sixth embodiment of a patientinterface device according to the principles of the present invention;

FIGS. 22-24 are a side, front, and exploded views, respectively, of thepatient interface device of FIG. 21;

FIG. 25 is a front perspective view of a seventh embodiment of a patientinterface device according to the principles of the present invention;

FIGS. 26-28 are a side, front, and exploded views, respectively, of thepatient interface device of FIG. 25;

FIG. 29 is an exploded view of a frame and circuit portion according toan eighth embodiment of the present invention;

FIG. 30 is a front perspective view of a ninth embodiment of a patientinterface device according to the principles of the present invention;

FIGS. 31-33 are front, rear, and side views, respectively, of thepatient interface device of FIG. 30;

FIGS. 34 and 35 are side and rear perspective views, respectively, of abody portion of the patient interface device of FIG. 30;

FIGS. 36 and 37 are front perspective and side views, respectively,illustrating the positioning of the patient interface device of FIG. 30on a user;

FIG. 38 is a side view of the patient interface device of FIG. 30;

FIGS. 39A-39D are front perspective, front, side, and top views,respectively, of an alternative embodiment for the patient interfaceportion of the patient interface device of FIG. 30;

FIG. 40 is a rear perspective view of an alternative embodiment for thebody portion of the patient interface device of FIG. 30;

FIGS. 41A and 41B are side perspective and rear views, respectively, ofyet another alternative embodiment for the body portion of the patientinterface device of FIG. 30;

FIG. 42 is a side perspective view of a still further alternativeembodiment for the body portion of the patient interface device of FIG.30;

FIG. 43 is a rear perspective view of a tenth embodiment of a patientinterface device according to the principles of the present invention;

FIG. 44 is partially exploded view of the patient interface device ofFIG. 41;

FIG. 45 is a perspective view of a pad suitable for use with the patientinterface device of FIG. 43;

FIG. 46 is a rear perspective view of an eleventh embodiment of apatient interface device according to the principles of the presentinvention;

FIG. 47 is a partially exploded view of the patient interface device ofFIG. 43;

FIG. 48 is a front perspective view of a twelfth embodiment of a patientinterface device according to the principles of the present invention;

FIG. 49 is an exploded view of the patient interface device of FIG. 46;

FIG. 50 is a front perspective view of a thirteenth embodiment of apatient interface device according to the principles of the presentinvention;

FIGS. 51 and 52 are front and bottom views, respectively, of the patientinterface device of FIG. 50;

FIG. 53 is a front perspective view a patient interface portion of thepatient interface device of FIG. 48;

FIG. 54 is a front perspective view a body portion of the patientinterface device of FIG. 50; and

FIGS. 55-57 are side perspective, bottom perspective, and front views,respectively of a fourteenth embodiment of a patient interface deviceaccording to the principles of the present invention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

FIGS. 1-4 illustrate a first embodiment of a patient interface device 30according to the principles of the present invention. Patient interfacedevice 30 is shown schematically connected to a pressure support system32 via a patient circuit 34, which communicates gas from the pressuresupport system to the patient interface device. Patient circuit 34 isany device, such as a flexible tubing, that carries the flow of gas fromthe pressure/flow generator in the pressure support system to thepatient interface device.

Pressure support system 32 is any conventional ventilation or pressuresupport system. Examples of such pressure support systems include, butare not limited to: a ventilator, continuous positive airway pressure(CPAP) device, or a variable pressure device, e.g. an auto-titratingdevice, proportional assist ventilation (PAV®) device, proportionalpositive airway pressure (PPAP®) device, C-Flex™ device, Bi-Flex™device, or a BiPAP® device manufactured and distributed by Respironics,Inc. of Pittsburgh, Pa., in which the pressure provided to the patientvaries with the patient's respiratory cycle so that a higher pressure isdelivered during inspiration than during expiration, or other pressuresupport device.

Patient interface device 30 includes a body portion 40, a circuitportion 50, and a patient interface portion 60. Body portion 40 includesa chin support 42, a pair of arms 44, and a circuit coupling portion 46.In the illustrated exemplary embodiment, body portion 40 is formed as asingle piece from a relatively rigid material. When the patientinterface device is donned by the user, chin support 42 passes under themandible from one side of the face to the other. Each one of arms 44extend from circuit coupling portion 46 to opposite ends of chin support42. Circuit coupling portion 46 attaches circuit portion 50 to the bodyportion.

The present invention contemplates providing a pad or multiple pads onchin support 42, arms 44, or both. Such pads can be made from anysuitable material or combination of materials, such as gel, foam,silicon. Example of gel materials suitable for use as these pads aredescribed in U.S. Pat. Nos. 5,647,357; 5,884,624; 6,397,847; and6,895,965 and pending U.S. patent application Ser. No. 11/715,760, filedMar. 8, 2007, publication no. 2007/0221227 (“the '760application”)(collectively referred to as “the gel references”), thecontents of each of which are incorporated herein by reference.

A plurality of headgear attachment elements 48 are provided on arms 44.In the illustrated exemplary embodiment, a headgear mount 52 attaches toone of the headgear attachment elements to attach a headgear strap 54 topatient interface device 30. Although three headgear attachment elements48 are shown as being provided on each arm, the present inventioncontemplates providing only or more than three such elements on thearms. The headgear attachment elements are any structure that is capableof attaching headgear mount 52 to the arm. In the illustratedembodiment, the headgear attachment elements are simply an openingdefined in the arm into which a male portion of the headgear inserts andis retained.

Of course, any fastening technique for joining the headgear strap, andhence, the headgear clip, to the support frame are contemplated by thepresent invention, including snaps, hooks, loops, clamps, or otherconnectors. Examples of fastening techniques suitable for use with thepresent invention are described in U.S. Pat. No. 7,066,179, the contentsof which are incorporated herein by reference.

The patient interface device of the present invention is located on theuser so that it is mounted on the chin. This is perhaps best shown withreference to FIGS. 36-38, which illustrate an embodiment of a patientinterface device 830 (described in greater detail below) mounted on theface of the user. A headgear assembly 100 including straps 54 maintainthe patient interface device on the user. The two regions of thepatient's face that primarily support the patient interface device onthe user are the chin (via the chin support) and the patient's nasalregion and/or nasal openings (via the patient interface portion).

The holding force that retains the patient interface device on the useris the headgear force provided by the headgear. This headgear force isdepicted as a vector force 900 in FIG. 38. The forces opposing theheadgear force include a nasal force 902, i.e., the force at the nasalcontact region, and a chin support force 904, i.e., the force at thechin or mandible contact region. A balance of force between the nose andchin is accomplished via a pivoting action about the chin support. Anexample of a pivot point is indicated by reference number 904. That is,as the strapping force is changed, the patient interface device pivotsat point 904 and the nasal interface portion moves about this pivotpoint as indicated by arrow 908. In other words, the arms of the bodyportion serve as a moment arm or level arm so that a relatively smallheadgear strapping force translates into a larger nasal force 902 beingneeded to counteract the headgear strapping force. The end result isthat a tight or effective seal can be created at the nasal region viathe nasal interface with a relatively small headgear strapping force.

By providing adjustability in the location where the headgear strappingforce is applied to the arm, for example by providing multiple headgearattachment elements 48 (848 in FIG. 38) along the length of the arm, theratio of nasal force to chin strap for any given headgear force can becontrolled. In other words, the headgear attachment locations on thearms define the dimensions d1 and d2. Changing these dimensions, permitsadjustment of the ratio of nasal force to chin strap force for any givenheadgear force. This is primarily accomplished as a result of thepivoting operability and the placement of the headgear attachmentlocations between the circuit portion and the chin support, i.e.,anywhere along the arms 44. Thus, a patient may selectively determinewhich configuration is most comfortable, providing an opportunity forgreater patient compliance for the therapy.

In the illustrated embodiment, patient interface portion 60 includes anasal cushion 62 having a single opening that seals around the nares ofthe user. Cushion 62 is attached to circuit portion 50 via aball-and-socket configuration. In the illustrated exemplary embodiment,the ball portion is provided on an end of circuit portion 50 and asocket is provided in patient interface portion 60.

Cushion 62 can be made from any suitable material, such as gel (see thegel references), silicone, foam, rubber, or combination of materials.Cushion 62 can also be formed from a highly elastic material, such asthat disclosed in U.S. patent application Ser. No. 11/266,808, filedNov. 3, 2005, publication no. 2006/0096598, the contents of which areincorporated herein by reference. The present invention furthercontemplates that cushion 62 includes one or more flaps provided at apatient contacting portion of the cushion. An example of a cushionhaving multiple flaps is disclosed in U.S. Pat. No. 4,971,051, thecontents of which are incorporated herein by reference. Furthermore,cushion 62 can include other structures, such as ribs, support members,varying wall thickness, and pleats to control the sealing characteristicof the cushion. An example of a cushion having pleats suitable for usein the present invention is disclosed in U.S. Pat. No. 7,237,551 (“the'551 patent), the contents of which are incorporated herein byreference.

An exhaust assembly 64 is defined in patient interface portion 60. Inthe illustrated embodiment, exhaust assembly 64 is defined by aplurality of vent holes provided in the wall of cushion 62. The number,size, hole pattern, and shape of the holes can have any configuration.One example of a multiple-hole type of exhaust assembly suitable for usein the present invention is disclosed in U.S. Pat. No. 6,851,425 (“the'425 patent”), the contents of which are incorporated herein byreference. It should also be noted that only one exhaust assembly needbe provided on the cushion 62, so long as the exhaust flow rate issufficient to provide an adequate exhaust gas venting function. Theexhaust assembly can also be omitted if exhausting gas from the systemis not needed or if the exhaust assembly is provided elsewhere, such asin the patient circuit.

FIGS. 5-8 illustrate a second embodiment of a patient interface device130 according to the principles of the present invention. Patientinterface device 130 includes a body portion 140, a circuit portion 150,and a patient interface portion 160. Body portion 140 includes a chinsupport 142 and a pair of arms 144. In this embodiment, circuit portion150 is part of, i.e., integral with, the body portion 140. That is, thebody portion is a one-piece structure with a passage formed in the bodyportion that defines a portion of the conduit that carries gas to andfrom the user. In an exemplary embodiment, the body member is a moldedpiece. A ball connection 164 is provided at one end of circuit portion150 to which patient interface portion 160 is selectively coupled. Aflexible conduit 152 defining a circuit portion is coupled to the otherend of the circuit portion. Any style or variety patient interfaceportion can be coupled to the body member. Likewise, any style orvariety of conduit can be coupled to the body member.

In the illustrated embodiment, patient interface portion 160 includes anasal cushion 162 that seals around both nares. Cushion 162 has aslightly different configuration from that of cushion 62 shown in FIGS.1-4. In addition, the exhaust assembly is not provided on the patientinterface portion. However, the exhaust assembly can be provided at anylocation or an different locations, including incorporating it into acoupling between portions of the gas flow path. Finally, a singleheadgear attachment element 148 is provided on each arm 144 of bodyportion 140.

FIGS. 9-12 illustrate a third embodiment of a patient interface device230 according to the principles of the present invention. Patientinterface device 230 includes a body portion 240, a circuit portion 250,and a patient interface portion 260. Body portion 240 includes a chinsupport 242 and a pair of arms 244. In this embodiment, chin support 240has cup-like configuration rather than a bar or strap that passes underthe chin.

A first adjustment assembly 270 is provided to control the angularposition of circuit portion 250 and a patient interface portion 260relative to body portion 240. First adjustment assembly 270 allows thepatient interface portion to rotate about a pivot point 272 so that thepatient interface portion can be moved toward and away from the user, asindicated by arrow 274. In the illustrated embodiment, this adjustmentassembly includes a ratchet-like mechanism that provided discretepositioning of circuit portion 250 relative to body portion 240. Thepresent invention also contemplates a continuous (non-discrete)adjustment mechanism for more freedom in selecting the position of thecircuit portion relative to the body portion.

A second adjustment assembly 280, in addition to or in place of thefirst adjustment assembly, can also provided to control the linearposition of circuit portion 250 and a patient interface portion 260relative to body portion 240. Second adjustment assembly 280 allows thepatient interface portion to move up and down in a direction generallyparallel to the centerline of the user, as indicated by arrow 282. Inthis illustrated embodiment, this is accomplished by providing arotating adjustment member 284 that is fixed in place, and a tube 286with treading 288 or partial threading on an exposed surface. Tube 286is disposed in adjustment member 284 so that the threading on the tubeengages corresponding threading on the interior surface of theadjustment member. Rotating the adjustment member causes the tube tomove up or down relative to the adjustment member to control.

Although not shown, one or more headgear attachment elements can beprovided on arms 244, a portion of chin support 242 spaced apart fromthe pivot point, on circuit portion 250, for example, at location 252,or any combination thereof.

FIGS. 13-16 illustrate a fourth embodiment of a patient interface device330 according to the principles of the present invention. Patientinterface device 330 includes a body portion 340, a circuit portion 350,and a patient interface portion 360. Body portion 340 includes a chinsupport 342 and a pair of arms 344. A headgear attachment element 348 isprovided in each arm.

In this embodiment, circuit portion 350 and body portion 340 are formedas a unitary structure. More specifically, in this embodiment, chinsupport 342 and a portion of circuit portion 350 is defined by a firstpiece 370 and the remaining portion of circuit portion 350 is defined bya second piece 372. First and second pieces 370 and 372 mate to formcircuit portion 350. Any conventional technique, such as a bonding,welding, mechanical connections, or any combination thereof, can be usedto join these two pieces. Of course, the present invention contemplatesdefining these portions of the patient interface device from more thanone piece. For example, first piece 370 or second piece 372, can beformed from multiple pieces that are assembled together.

Circuit portion 350 includes a pair of conduits 352 that are connectedor joined together at one end to form a Y-connector configuration. Theother ends of conduits 352 are coupled to each side of patient interfaceportion 360, which in this embodiment, is a nasal cushion 362. In anexemplary embodiment, patient interface portion 360 is rotatably coupledto the ends of conduit 352 so that the nasal cushion can rotate relativeto the conduits, as indicated by arrow 354 in FIG. 14. An exhaustassembly (not shown) can be provided in circuit portion 350, a patientinterface portion 360, or both.

FIGS. 17-20 illustrate a fifth embodiment of a patient interface device430 according to the principles of the present invention. Patientinterface device 430 includes a body portion 440, a circuit portion 450,and a patient interface portion 460. Body portion 440 includes a chinsupport 442 and a pair of arms 444. A headgear attachment element 448 isprovided in each arm. In this embodiment, patient interface portion 460is defined by a pair of nasal cushions 462 rather than a single cushion,and circuit portion 450 includes a double swivel that allows rotation intwo planes, ninety degrees from one another, as indicated by arrows 452and 454.

Patient interface portion 460 is also defined by a support member 464that couples to an end of circuit portion 450 and a cushion assembly466, which includes nasal cushions 462, that couples to the supportmember. Support member 464 is more rigid than cushion assembly 466. Inan exemplary embodiment, the support member is defined from a plastic,and the cushion assembly is defined by a unitary piece of flexiblematerial, such as silicon. The support member and cushion assembly 466are coupled together in any suitable fashion using any conventionaltechnique. In one embodiment, these two components are selectivelyattached so that the cushion assembly can be easily removed andreplaced.

In the illustrated embodiment, nasal cushions 462 have a general“mushroom” configuration with a stem portion and a head portion, both ofwhich are formed from a flexible material, such as silicon. Of course,the portions of the prongs can be formed from different materials. Forexample, the head can be formed of foam or gel and the stem formed fromsilicon. In addition, the nasal cushions can have a variety ofconfigurations, such as dome-shaped, and can have other features, suchas bellows, pleats, and grooves that enable the position, orientation,or angle of the prongs to move or be adjusted to match the anatomicalfeatures of the user. Examples of other nasal prongs suitable for use inthe sealing assembly of the present invention are described in U.S.patent application Ser. No. 11/074,410, filed Mar. 8, 2005 (Pub. No.US-2005-0199242-A1), the contents of which are incorporated herein byreference, and in U.S. Pat. No. 7,178,525, the contents of which areincorporated herein by reference.

A swivel connector 456 is coupled to body portion 440 so that thepatient circuit that couples the pressure support system can move freelyrelative to the body portion. This prevents or minimizes torque in thepatient circuit from being translated to the body member, which may tendto compromise the seal created by patient interface portion 460. In theillustrated embodiment, swivel connector 456 is defined by a firstcoupling member 458 that is rotatably coupled to circuit portion 450 anda second coupling member 459 that is rotatably coupled to first couplingmember 458. First and second coupling members 458 and 459 are shown as90° elbows. However, the present invention contemplates that one or bothof these coupling members can have other configurations, such as otherangles or no angle/bend.

FIGS. 21-24 illustrate a sixth embodiment of a patient interface device530 according to the principles of the present invention. Patientinterface device 530 includes a body portion 540, a circuit portion 550,and a patient interface portion 560. Body portion 540 includes a chinsupport 542 and a pair of arms 544. In this embodiment, circuit portion550 is integral with body portion 540 so that both are defined from aunitary structure, such a molded piece. Circuit portion 550 isconfigured to provide separate supports 552 with a cushion couplingmember 554 provided at the end of each support. Nasal cushions 562 arecoupled to cushion coupling members 554 in a ball-and-socketconfiguration, so that the nasal cushion can rotate and move relative tothe cushion coupling members. This allows the nasal cushions to moveindependently to fit a wide variety of users.

Headgear attachment elements 548 are provided on arms 544. In thisembodiment, the headgear attachment elements are a track or slot thathas multiple, discrete position points along the length of the track.The headgear clip (not shown) connects to the track anywhere along itslength and can be moved along the track so that the user can select theoptimal location to provide the desired sealing force for the patientinterface portion 560 against the nasal region.

FIGS. 25-28 illustrate a seventh embodiment of a patient interfacedevice 630 according to the principles of the present invention. Patientinterface device 630 includes a body portion 640, a circuit portion 650,and a patient interface portion 660. Body portion 640 includes a chinsupport 642, a pair of arms 644, and a circuit coupling portion 646. Inthis embodiment, circuit portion 650 is defined by a conduit member 651that selectively attaches to body portion 640 via circuit couplingportion 646.

The present invention contemplates that any technique and configurationcan be provided for conduit member 651 and circuit coupling portion 646.In the illustrated exemplary embodiment, conduit member 651 includesseparate supports 652 with a cushion coupling member 654 provided at theend of each support. Nasal cushions (not shown) couple to cushioncoupling members 654 in a ball-and-socket configuration. Conduit member651 is a relatively rigid and structure and circuit coupling portion 646is also a relatively rigid structure that has a configuration thatgenerally matches that of the conduit member. This allows the conduitmember to snap together with circuit coupling portion 646 for easy ofassembly and replacement. The “Y” shape for conduit member 651 providesa snug fit and controlled positioning for the conduit member relative tothe circuit coupling portion.

FIG. 29 illustrates a body portion 740 and a circuit portion 750 of apatient interface device 730 according to an eighth embodiment of thepresent invention. This patient interface device is generally similar tothat of FIGS. 25-28, except for chin support 742. In the previouslydescribed embodiments, the chin support portion of the body member is arelatively rigid or semi-rigid structure that spans between the arms ofthe body member. In this embodiment, however, chin support 742 is aflexible structure, such as a strap or a padded strap, that spansbetween arms 744. It is believed that making the chin support flexibleenhances or facilitates the pivoting action of the patient interfacedevice.

Attachment structures 745 are provided on arms 744 to attach theflexible chin support to the arms. In this embodiment, attachmentstructures form slots into which the chin strap inserts. It is to beunderstood that a myriad of other structures, such as snaps, hooks,clips, tabs, pins, and multiple slots, or any combination thereof, canbe used to couple chin support 742 to the arms. The present inventionalso contemplates making the length of chin support 742 adjustable sothat the patient interface device can be altered to fit a variety ofusers. It should also be expressly understood that this flexible chinsupport configuration can be used in any of the other embodiments of thepresent invention.

FIGS. 30-38 illustrate a ninth embodiment of a patient interface device830 according to the principles of the present invention. Patientinterface device 830 includes a body portion 840, a circuit portion 850,and a patient interface portion 860. Body portion 840 includes a chinsupport 842 and a pair of arms 844. In this embodiment, circuit portion850 and body portion 840 are integral with one another so that a gasflow path is defined through the patient interface device. Arms 844include multiple headgear attachment elements 848 in the form of slotsthat are angled to match the angle of attach for the headgear strap 54when the patient interface device is worn by the user. Attachmentstructures 845, also in the form of slots, are provided at the ends ofarms 844. Chin support 842, which is a flexible strap, inserts throughthese slots. The present invention contemplates that this chin strap isa padded strap that passes through the attachment structures and loopsback on itself. A hook and loop fastener is provided on the strap sothat the length of the strap can be adjusted.

Patient interface portion 860 includes a cushion 861 that attaches tocircuit portion 850. In the illustrated exemplary embodiment, cushion861 includes a base 863 and a pair of nasal cushions 862 attached to thebase. In this exemplary embodiment, the nasal cushions and the base areformed as a unitary structure. However, the present invention alsocompletes that the nasal cushions be selectively attachable to the baseso that different types, sizes, shapes, etc. of nasal cushions can beused. A gas flow passage is defined in the base from the bottom of thebase to and through the nasal cushions.

A best shown in FIGS. 34 and 35, circuit portion 850 includes a cushionattachment member 852 to which cushion 861 attaches in a male-femaleconfiguration. A cavity is defined in base 863 of cushion 831 having ashape that generally matches the shape of cushion attachment member 852.The cushion attaches to the circuit portion by sliding the base overcushion attachment member 852. The flexibility of the base allows it toflex around the cushion attachment member and the resiliency of the basemaintains the attachment.

In the illustrated exemplary embodiment, cushion attachment member 852has a barrel shape (and the cavity in the cushion has a similar barrelshape) so that the cushion can be moved or rotated relative to bodymember 830 as indicated by arrow 854 in FIG. 33. The barrel shape,unlike a ball-and-socket, allows movement (rotation) in only one plane.Optional pins 856 can be provided on the sides (ends) of the barrel tohelp maintain the attachment between the cushion and the cushionattachment member 852 and allow the user to rotate the cushion about afixed point and without dislodging it from the cushion attachmentmember. A passage 870 is defined through circuit portion 850, includingthrough cushion attachment member 852. An opening 872 is defined in theside of the cushion attachment member so that gas flows between circuitportion 850 and cushion 861.

FIGS. 39A-39C are front perspective, front, side, and top views,respectively, of an alternative embodiment a patient interface portion880 suitable for se in the patient interface device of FIGS. 30-38. Inother words, patient interface portion 880 can be used in place ofpatient interface portion 860 in the patient interface device of FIGS.30-38. Patient interface portion 880 is a nasal cushion type ofinterface, somewhat similar to nasal cushions 62, 162, 362 of theprevious embodiments. Patient interface portion 880 includes a unitaryor single-piece cushion 881 that attaches to circuit portion 850. In theillustrated exemplary embodiment, cushion 881 includes a base 883 and anasal interface portion 882 attached to the base. The present inventioncontemplates that cushion 881 is formed from a material that provides asufficient amount of support for base 883 and while providing relativeflexibility for nasal interface portion 882. In an exemplary embodiment,the cushion is formed from silicone, with the base portion being thickerthan the nasal interface portion to provide the different degrees ofsupport/flexibility for each portion.

In this exemplary embodiment, nasal interface portion 882 includes apatient contacting surface 884 that is contoured to generally correspondto the underside of the human nose. An opening 886 is provided insurface 884 and sized such that both of the user's nares are covered bythe opening so that a flow of gas is communicated to both the nares viathe opening. A pleat or groove 888 is also defined in the cushionbetween nasal interface portion 882 and base portion 883. Groove 888allows nasal interface portion 882 to move so that its can adjust tofit/seal a variety of different types of faces and noses.

In the illustrated embodiment, groove 888 is defined around the frontand sides of the nasal cushion, but is not provided in the back, i.e.,the side of the cushion that faces the user when the patient interfacedevice is being worn. The present invention, contemplates, however,providing the groove around the entire perimeter of the cushion. Thepresent invention also contemplates providing multiple grooves in thecushion, and providing one or more grooves in other locations on thecushion. In addition the groove or grooves can have different sizes,shapes, and configurations. The '026 application teaches a mask havinggrooves and/or various groove configurations suitable for use in thisembodiment of the present invention.

An opening 890 is provided in base portion 883 to communicate theinterior of the nasal cushion with the patient circuit portion of thepatient interface device. In addition, openings or receptacles 892 areprovided in the sides of the nasal cushion to receive pins 856 of thecushion attachment member of the circuit portion.

FIG. 40 is a rear perspective view of an alternative embodiment for abody portion 910 the patient interface device of FIG. 30-38. As in theprevious embodiment, the body portion includes a pair or arms 844 thatattach to a circuit portion 850. In this embodiment, however, the bodyportion includes an oral member 912 adapted to cover the mouth. Onepurpose for covering the mouth is to seal the lips closed so thatmouthing breathing or leakage of gas through the mouth during thepressure support therapy is minimized.

In the exemplary embodiment illustrated in FIG. 40, oral member 912 is aflexible or semi-rigid strap 914 that extends between the pair of arms844. Strap 914 is positioned sized and configured such that it overliesand presses against the lips of the user when the patient interfacedevice is donned by the user. The present invention contemplates thatstrap 914 can have a variety of other sizes, shapes, and configurationsso long as the purpose of sealing the mouth and/or lips of the user isachieved. Strap 914 is connected to arms 844 in any suitable manner. Inan exemplar embodiment, strap 914 is adjustable so that the length ofthe strap, and, hence, the force against the mouth/lips of the user canbe controlled. In addition, the present invention contemplates providingmultiple attachments points along the length of arms 844 so that therelative position of the strap on the arms can be adjusted. This, ineffect, allows the position of the strap relative to the user to becontrolled.

FIGS. 41A-42 illustrate other alternative embodiments for the bodyportion of patient interface device of FIG. 30. More specifically, FIGS.41A and 41B show a first alternative configuration for the oral member.In this embodiment, oral member 922 includes a lip sealing assembly 924that is operatively coupled to circuit portion 850 of the patientinterface device. Lip sealing assembly 924 can also be coupled to one orboth of the pair of arms 844.

In the illustrated exemplary embodiment, lip sealing assembly 924includes a seal 926 that inserts into the mouth behind the lips and infront of the teeth. Seal 926 is formed from a flexible material so thatit can bend to fit the user's mouth. It can also be formed from a stiffmaterial that is capable of being molded to fit the user's mouth. Theseal can also be trimmed, bent, or otherwise reconfigured to fit theuser. Notches 928 or other shape controlling mechanisms can be providedon the perimeter of or at other locations on the seal to facilitatebending or altering of the shape of the seal.

Seal 926 is coupled to circuit portion 850 via a connecting member 930.In this embodiment connecting member 930 includes a passage 932 thatcommunicates with the passage defined in the circuit portion 850 so thata flow of gas is provided to the user's mouth in addition to the flow ofgas provided to the user's nose via patient interface portion 860.Connecting member 930 can be rigid or flexible and can be permanently orselectively attachable to the circuit portion or the seal. Making theconnecting member and the seal selectively attachable to one another andmaking the connecting member selectively attachable to the circuitportion allows a high degree of flexibility for the user in selectingthe right size connecting member and seal for their mouth and face. Thepresent invention also contemplates that the length of connecting member930 can be adjustable, for example, by providing a threaded connectionto the circuit portion or by making the connecting member telescoping,so that the user can move the connecting member to fit them.

As best shown in FIG. 41B, the present invention contemplates providinga tooth contacting member 934 that fits between the user's teeth. Toothcontacting member 934 serves as a bite block to prevent the user fromcompletely closing his or her mouth. This allows gas to flow between,rather than through, the teeth. Tooth contacting member 934 can have avariety of different configurations. In the illustrated embodiment, itis merely an oval shaped tube that inserts between the teeth and extendsa short distance beyond the teeth into the oral cavity.

FIG. 42 shows alternative configuration for an oral member 940 thathelps appreciate the variety of different configurations that arepossible for the oral member. In this embodiment, oral member 940includes a bite block 942 that is attached to circuit portion 850 via aconnecting member 944. Connecting member 944 is a rigid or flexibleattachment to the circuit portion, and does not include a gas flowpassage. Thus, bite block 942 helps secure the patient interface deviceto the user, and does not provide a gas flow to the user's mouth.

Bite block 942 has an upper portion or upper tray 946 and a lowerportion or lower tray 948. Upper tray 946 engages the upper teeth andlower tray 948 engages the lower teeth. Upper and lower trays 946, 948can be formed from an suitable material. In a further embodiment, thesetrays are configured to hold a tooth engaging material so that the biteblock can be customized to the user's dentition.

In this embodiment, the upper and lower trays are formed as a unitarystructure. The present invention also contemplates forming eachseparately. In which case, the upper and lower trays can be moveablerelatively to one another to control the position of the mandible. Thetrays can be also be adjustable relatively to one another so that theuser or caregiver can select the position that accomplishes whateverfunction is desired. For example, the trays can be set to a positionthat achieve maximum comfort for that particular user. The trays canalso be set to move the mandible from its normal position, which isdone, for example, to treat snoring and/or OSA.

In the illustrated embodiment, the upper and lower trays are alsogenerally aligned with one another so that the user's upper and lowerteeth mesh in a normal, mouth closed fashion. The present invention alsocontemplates offsetting the upper and lower trays from one another. Forexample, the lower tray can be set forward of the upper tray so that theuser's mandible is advanced from its normal resting position. This isdone, as noted above, to keep the airway open to treat OSA.

FIGS. 43-45 illustrate a tenth embodiment of a patient interface device1030 according to the principles of the present invention. Patientinterface device 1030 includes a body portion 1040, a circuit portion1050, and a patient interface portion 1060. Body portion 1040 includes achin support 1042 and a pair of arms 1044. Patient interface device 1030is generally similar to patient interface device 530 of FIGS. 21-24 inthat circuit portion 1050 is integral with body portion 1040 so thatboth are define a unitary structure, i.e., a single molded part. Circuitportion 1050 is configured to provide separate supports 1052 with acushion coupling member 1054 provided at the end of each support. Nasalcushions or prongs 1062 are coupled to cushion coupling members 1054 ina ball-and-socket configuration, so that the nasal cushion can rotateand move relative to the cushion coupling members and independent of oneanother.

Headgear attachment elements 1048 are provided on arms 1044. In thisembodiment, the headgear attachment elements are keyed slots that enablea headgear clip (not shown) to connect to the arms. In this embodiment,chin support 1042 is a relative rigid or semi-rigid structure supportinga chin pad 1070. In this embodiment, chin pad 1070 is selectivelyattachable to chin support 1042 and covers a majority of the chinsupport when so attached. A surface 1071 of the pad serves as thepatient contact portion. The preset invention contemplates that surface1071 can be made from the same material as the rest of the chin supportor it can be made from other materials suitable for use in contacting apatient, especially for an extended period of time, such as a gel, foam,or other soft material.

To enable chin pad 1070 to selectively attach to chin support 1042, theillustrated embodiment of the present invention includes providing apocket 1072 in the chin pad into which the chin support, or a portionthereof, inserts. A flap 1074 is coupled to the main portion of the chinpad and folds over, as indicated by arrow 1076 to close the pockettrapping the chin support in the pocket, thus securing the chin pad tothe chin support. The flap is secured to the chin pad via an attachmentmechanism 1078, which can be any conventional type of fastener. Forexample, attachment mechanism 1078 is as a hook and loop faster, such asVELCRO®, where the hooks are provided on flap 1074 and the softer loopsare provided on the pad. Slots 1080 can be provided on the arms 1044and/or chin support 1042 to secure or help secure the chin pad to thechin support. This embodiment is advantageous because, for example, itallows the chin pad to be easily removed and replaced or cleaned.

FIGS. 46 and 47 illustrate an eleventh embodiment of a patient interfacedevice 1130 according to the principles of the present invention.Patient interface device 1130 includes a body portion 1140, a circuitportion 1150, and a patient interface portion 1160. Body portion 1140includes a chin support 1142, a pair of arms 1144, and a circuitcoupling portion 1146 that is couple to the arms. Patient interfacedevice 1130 is generally similar to patient interface device 30 of FIGS.1-4 in that circuit portion circuit coupling portion 1146 is coupled tothe arms and couples a circuit portion 1150 to the body portion. In thisembodiment, circuit coupling portion 1146 is integral with arms 1144 sothat they define a unitary structure, i.e., as a single molded piece orpart. In addition, patient interface portion 1160, as illustrated, isgenerally similar to patient interface portion 60. Of course, thepresent invention contemplates that any suitable patient interfaceportion can be used in patient interface device 1130, including forexample, a pair of nasal prongs.

Headgear attachment elements 1148 are provided on arms 1144. In thisembodiment, the headgear attachment elements are slots provided in arms1144. The headgear straps can be connected direction to these slots orthey can be connected to the slots via a headgear clip (not shown). Inthis embodiment, chin support 1142 is a relative rigid or semi-rigidstructure supporting a chin pad 1170. Chin pad 1170 is selectivelyattachable to chin support 1142 and covers a majority of the chinsupport when so attached. A surface 1171 of the pad serves as thepatient contact portion. The preset invention contemplates that surface1171 can be made from the same material as the rest of the chin supportor it can be made from other materials suitable for use in contacting apatient, especially for an extended period of time, such as a gel, foam,or other soft material.

To enable chin pad 1170 to selectively attach to chin support 1142, theillustrated embodiment of the present invention includes slots 1172 inthe chin pad. These slots receive the end portions of the chin support,the end portions of the arms, or both. Slots 1174 are provided on arms1144 and/or chin support 1142 to secure or help secure the chin pad tothe chin support. This embodiment is advantageous because, for example,it allows the chin pad to be easily removed and replaced or cleaned. Itshould be understood that the chin pad can have a variety of differentconfigurations, sizes, shapes, and be made from a variety of materialsor combinations of materials.

FIGS. 48 and 49 illustrate a twelfth embodiment of a patient interfacedevice 1230 according to the principles of the present invention.Patient interface device 1230 includes a body portion 1240 and a patientinterface portion 1260. Body portion 1240 includes a chin support (notshown), a pair of arms 1244, and a circuit coupling portion 1246 that iscoupled to the arms. In this embodiment, circuit coupling portion 1246defines or serves that the circuit portion of the patient interfacedevice. Patient interface device 1230 in this embodiment provides a fullface type of patient interface that covers both the user's nasalpassages and mouth.

Attachment structures 1245 are provided on arms 1244 to coupled the chinsupport to the body portion. In the illustrated embodiment, attachmentstructures 1245 include a pair of slots provided in each arm. The chinsupport can be coupled to one or both to these slots. Providing multipleslots gives the user greater flexibility in configuring the patientinterface device to suit his or her particular facial features.

Headgear attachment elements 1248 are also provided on body portion 1240so that headgear straps (not shown) can be coupled to the body portion.In this embodiments, attachment elements 1248 are provided in the formof slots provided, not on arms 1244, but an a central portion 1249 ofthe body member. It should be noted that the location of attachmentelements 1248 still enables the arms of the body portion to serve as amoment arm or level arm, so that a relatively small headgear strappingforce applied to attachment elements 1248 translates into a larger nasalforce being needed to counteract the headgear strapping force, therebyproviding a tight or effective seal of patient interface portion 1260against the surface of the user with a relatively small headgearstrapping force.

Patient interface portion 1260 is coupled to central portion 1249 ofbody portion 1240 such that arms 1244 extend beyond the sides of thepatient interface portion toward the user. To facilitate the attachmentof the patient interface portion to the body portion, the body portionincludes an opening 1250 and the patient interface portion includes aprotrusion 1262. Protrusion 1262 is sized and configured to fit snuglyinto opening 1250, and both are configured such that the patientinterface portion is assembled with the body portion, there is little orno movement, such as rotation of the these components relative to oneanother.

Circuit coupling portion 1246 provides a connection to a patient circuitcoupling 1270 so that a flow of gas can be communicated between apatient circuit (not shown) and the interior of patient interfaceportion 1260. An opening 1264 is provided in patient interface portion1260 and an opening is provided in circuit coupling portion 1246 todefine a gas flow path through the patient interface device. In theillustrated exemplary embodiment, patient circuit coupling 1270 is anelbow coupling that rotatably and releasably attaches to circuitcoupling portion 1246. To provide the releasably attachment of thepatient circuit coupling to the circuit coupling portion of the bodymember, patient circuit coupling 1270 includes a pair of clamps 1272that engage a rim 1252 on circuit coupling portion 1246. Squeezing theclaims together releases a free end of the arms defining the clamps fromthe rim so that the patient circuit coupling can be detached from thecircuit coupling portion.

Although not shown, the present invention contemplates providing anentrainment valve and/or exhaust assembly on patient circuit coupling1270. Example of suitable entrainment valves and exhaust assemblies aredisclosed in the '425 patent. Of course the exhaust assemble can beprovided at other locations, such as in the patient interface portion,the body member, or in any combination of locations. The patientinterface portion can also include one or more pleats or grooves, andcan include one or more flaps at the patient contacting side.

FIGS. 50-54 illustrate a thirteenth embodiment of a patient interfacedevice 1330 according to the principles of the present invention.Patient interface device 1330 includes a body portion 1340 and a patientinterface portion 1360. Body portion 1340 includes a chin support (notshown), a pair of arms 1344, and a circuit coupling portion 1346 that iscoupled to the pair of arms. As in the previous embodiment, circuitcoupling portion 1346 serves that the circuit portion of the bodyportion of the patient interface device. Attachment structures 1345 areprovided on arms 1344 to coupled the chin support to the body portion.Patient interface device 1330 is generally similar to patient interfacedevice 1230 of FIGS. 48 and 49 in that it is also a full-face type ofnasal interface, covering both the nares and mouth. This embodiment isprovided mainly to illustrate further possible variations that can beprovided in the features that make up the patient interface device.

In this embodiment, for example, body portion 1340 includes a pair ofattachment elements 1348 to attach to headgear straps (not shown). Thepresent invention contemplates that only one pair of these attachmentstructures will be used to couple the headgear to the patient interfacedevice. Providing multiple pairs gives the user freedom and flexibilityin selecting the par of attachment structures for attaching the headgearto the mask that is best suited, e.g., most comfortable, stable, and/orminimizes unintentional leakages, for that user.

Body portion 1340 includes a pair of opening or cavities 1362 a and 1362b adapted to receive corresponding protrusions 1349 a and 1349 b ofpatient interface portion 1340. As in the previous embodiment, thesefeatures are provided to facilitate the attachment of the patientinterface portion to the body portion. When assembled, there is littleor no movement, such as rotation or sliding, of the body portionrelative to the patient interface portion.

Circuit coupling portion 1346 provides a connection to a patient circuitcoupling, such as that shown in the other figures, so that a flow of gascan be communicated between a patient circuit and the interior ofpatient interface portion 1360. An opening 1364 is provided in patientinterface portion 1360 and a corresponding opening 1347 is provided incircuit coupling portion 1346 to define a gas flow path through thepatient interface device. In this embodiment, a portion of circuitcoupling portion 1346 extends from the body member and provides amounting surface for the patient interface portion. More specifically,opening 1364 fits over circuit coupling portion 1346 to connect theportions of the patient interface device together to provide a gas flowpath into and out of the patient interface portion.

FIGS. 55-57 illustrate a fourteenth embodiment of a patient interfacedevice 1430 according to the principles of the present invention.Patient interface device 1430 includes a body portion 1440 and a patientinterface portion 1460. Body portion 1440 includes a chin support 1442(shown in dashed lines), a pair of arms 1444, and a circuit couplingportion 1446 that is coupled to the pair of arms. Attachment structures1445 are provided on arms 1444 to coupled the chin support to the bodyportion. In addition, attachment elements 1448 are also provided on arms1444 to couple a headgear strap (not shown) to the body member.

Patient interface device 1430 is generally similar to patient interfacedevices 1230 and 1330 of FIGS. 48-54 in that it too is a full-face typeof nasal interface, covering both the nares and mouth. This embodimentillustrates ever further possible variations that can be provided in thefeatures that make up the patient interface device. n A patient circuitcoupling 1470 is coupled to circuit coupling portion 1446 so that a flowof gas can be communicated between a patient circuit (not shown) and theinterior of patient interface portion 1460. In the illustrated exemplaryembodiment, patient circuit coupling 1470 is an elbow coupling thatrotatably and releasably attaches to circuit coupling portion 1446.

In this embodiment, body portion 1430 includes a forehead supportportion 1480 that extends to the forehead area of the user. Foreheadsupport can have any one of a variety of different features, sizes,configurations, including, for example, making the forehead supportadjustable relative to the remainder of the body member. U.S. Pat. No.7,069,932, the contents of which are incorporated herein by reference,teaches examples of adjustable forehead support assemblies suitable foruse in the present invention.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

1. A patient interface device comprising: (a) a body portion comprising:(1) a pair of arms, (2) a chin support, wherein a first end portion ofeach arm in the pair of arms is coupled to an opposite end of the chinsupport, and wherein the chin support is adapted to be disposed underthe mandible of a user responsive to the patient interface device beingdonned by such a user, (3) a pair of headgear attachments, and (4) acircuit portion operatively coupled to a second end portion of each armin the pair of arms, wherein each headgear attachment in the pair ofheadgear attachments is disposed on each arm in the pair of arms betweenthe first end portion and the second end portion; and (b) patientinterface portion operatively coupled to the circuit portion.
 2. Thepatient interface device of claim 1, wherein the patient interfaceportion includes one of a pair of a nasal prongs, a nasal cushion, and afull face cushion.
 3. The patient interface device of claim 1, whereinthe chin support comprises a flexible strap.
 4. The patient interfacedevice of claim 1, wherein the chin support comprises one of a rigidmember, a semi-rigid member, and a pad.
 5. The patient interface deviceof claim 1, wherein the patient interface portion is adjustably coupledto the circuit portion.
 6. The patient interface device of claim 1,further comprising an exhaust assembly associated with the patientinterface portion, the circuit portion, or both.
 7. The patientinterface device of claim 1, wherein the pair of arms are (a) integralwith the circuit portion, or (b) selectively attachable to the circuitportion.
 8. The patient interface device of claim 1, wherein the circuitportion includes (a) a single gas flow conduit in fluid communicationwith the patient interface portion, or (b) a pair of gas flow conduitsin fluid communication with the patient interface portion.
 9. Thepatient interface device of claim 1, further comprising an oral memberadapted to (a) cover a mouth of such a user, or (b) seal an oral passageof such a user.
 10. The patient interface device of claim 9, wherein theoral member is (a) a strap extending between the pair of arms, or (b) alip sealing assembly operatively coupled to the circuit portion or thepair of arms and adapted to be inserted into a mouth of such a user pastsuch a user's lips.
 11. The patient interface device of claim 1, furthercomprising a mouthpiece coupled to the body portion.
 12. The patientinterface device of claim 11, further comprising an oral path defined inthe mouthpiece so as to communicate the circuit portion with the oralcavity responsive to the patient interface device being worn by such auser.
 13. The patient interface device of claim 1, further comprising aheadgear operatively coupled to the pair of headgear attachmentelements.
 14. The patient interface device of claim 1, wherein thepatient interface is a nasal cushion including at least one groovedefined in a wall portion of the nasal cushion.